Methods and apparatus for selectively occluding the lumen of a needle

ABSTRACT

A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/490,099, filed Sep. 18, 2014, entitled “Methods and Apparatus forSelectively Occluding the Lumen of a Needle,” now U.S. Pat. No.9,788,774, which is a continuation of U.S. patent application Ser. No.14/200,453, filed Mar. 7, 2014, entitled “Methods and Apparatus forSelectively Occluding the Lumen of a Needle,” which claims priority toand the benefit of U.S. Provisional Patent Application Ser. No.61/777,758 entitled, “Lumenless Needle for Bodily Fluid SampleCollection,” filed Mar. 12, 2013, the disclosures of which areincorporated herein by reference in their entirety.

BACKGROUND

Embodiments described herein relate generally to transferring fluid toor from a patient, and more particularly to devices and methods fortransferring fluid to or from a patient with reduced contamination frommicrobes or other contaminants exterior to the body and/or the fluidsource, such as dermally residing microbes.

Human skin is normally habituated in variable small amounts by certainbacteria such as coagulase-negative Staphylococcus species,Proprionobacterium acnes, Micrococcus species, Streptococci Viridansgroup, Corynebacterium species, and Bacillus species. These bacteria forthe most part live in a symbiotic relationship with human skin but insome circumstances can give rise to serious infections in the bloodstream known as septicemia. Septicemia due to these skin residingorganisms is most often associated with an internal nidus of bacterialgrowth at the site of injured tissue, for example a damaged, scarredheart valve, or a foreign body (often an artificial joint, vessel, orvalve). Furthermore, there are predisposing factors to these infectionssuch as malignancy, immunosuppression, diabetes mellitus, obesity,rheumatoid arthritis, psoriasis, and advanced age. In some instances,these infections can cause serious illness and/or death. Moreover, theseinfections can be very expensive and difficult to treat and often can beassociated with medical related legal issues.

In general medical practice, blood is drawn from veins (phlebotomy) fortwo main purposes; (1) donor blood in volumes of approximately 500 mL isobtained for the treatment of anemia, deficient blood clotting factorsincluding platelets and other medical conditions; and (2) smallervolumes (e.g., from a few drops to 10 mL or more) of blood are obtainedfor testing purposes. In each case, whether for donor or testingspecimens, a fluid communicator (e.g., catheter, cannula, needle, etc.)is used to penetrate and enter a vein (known as venipuncture) enablingthe withdrawal of blood into a tube or vessel apparatus in the desiredamounts for handling, transport, storage and/or other purposes. The siteof venipuncture, most commonly the antecubital fossa, is prepared bycleansing with antiseptics to prevent the growth of skin residingbacteria in blood withdrawn from the vein. It has been shown thatvenipuncture needles dislodge fragments of skin including hair and sweatgland structures as well as subcutaneous fat and other adnexalstructures not completely sterilized by skin surface antisepsis. Theseskin fragments can cause septicemia in recipients of donor bloodproducts, false positive blood culture tests, and other undesirableoutcomes. Furthermore, methods, procedures and devices are in use, whichdivert the initial portion of venipuncture blood enabling exclusion ofthese skin fragments from the venipuncture specimen in order to preventsepticemia in recipients of donor blood products, false positive bloodculture tests and other undesirable outcomes.

Venipuncture is also the most common method of accessing the bloodstream of a patient to deliver parenteral fluids into the blood streamof patients needing this type of medical treatment. Fluids in containersare allowed to flow into the patient's blood stream through tubingconnected to the venipuncture needle or through a catheter that isplaced into a patient's vasculature (e.g. peripheral IV, central line,etc.). During this process, fragments of incompletely sterilized skinwith viable skin residing microbes can be delivered into the bloodstream with the flow of parenteral fluids and/or at the time ofvenipuncture for introduction and insertion of a peripheral catheter.These fragments are undesirable in the blood stream and theirintroduction into the blood stream of patients (whether due todislodging of fragments by venipuncture needle when inserting a catheteror delivered through tubing attached to needle or catheter) is contraryto common practices of antisepsis. Further, these skin fragments withviable microbes can be associated with a well-known phenomenon ofcolonization by skin residing organisms of the luminal surface of tubingand tubing connectors utilized to deliver parenteral fluids. Thecolonization is not typically indicative of a true infection but cangive rise to false positive blood culture tests, which may result inantibiotic treatment, laboratory tests, and replacement of the tubingapparatus with attendant patient risks and expenses all of which areunnecessary. Furthermore, the risk of clinically significant seriousinfection due to skin residing organisms is increased.

As such, a need exists for improved fluid transfer devices, catheterintroduction techniques and devices, as well as methods for transferringfluid to or from a patient with reduced microbial contamination andinadvertent injection of undesirable external microbes into a patient'sblood stream.

SUMMARY

Devices and methods for delivering a fluid to a patient and/orintroducing a peripheral catheter with reduced contamination fromdermally residing microbes or other contaminants exterior to the bodyare described herein. In some embodiments, a fluid transfer device forparenterally transferring fluid to and/or from a patient includes ahousing, a needle, and an occlusion mechanism. The housing defines afluid flow path and is couplable to a fluid reservoir. The needle has adistal end portion that is configured to be inserted into the patientand a proximal end portion that is configured to be fluidically coupledto the fluid flow path of the housing. The needle defines a lumenbetween the proximal end portion and the distal end portion. Theocclusion mechanism is operable to selectively control a fluid flowbetween the needle and the fluid flow path. The occlusion mechanismincludes an occlusion member that is movable between a firstconfiguration where the lumen of the needle is obstructed duringinsertion into the patient and a second configuration where the lumen ofthe needle is unobstructed after the needle has been inserted into thepatient allowing fluid transfer to or from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are schematic illustrations of a fluid transfer device ina first configuration and a second configuration, respectively,according to an embodiment.

FIG. 3 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 4 is a cross-sectional view of the fluid transfer device of FIG. 3taken along the line X₁-X₁, while in a first configuration.

FIG. 5 is a cross-sectional view of the fluid transfer device of FIG. 3taken along the line X₁-X₁, while in a second configuration.

FIG. 6 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 7 is a cross-sectional view of the fluid transfer device of FIG. 6taken along the like X₂-X₂, while in a first configuration.

FIG. 8 is an enlarged view of a portion of the fluid transfer device ofFIG. 6 in the first configuration and identified in FIG. 7 as region Z₁.

FIG. 9 is an enlarged view of a portion of the fluid transfer device ofFIG. 6 in the first configuration and identified in FIG. 7 as region Z₂.

FIG. 10 is a cross-sectional view of the fluid transfer device of FIG. 6taken along the line X₂-X₂, while in a second configuration.

FIG. 11 is an enlarged view of a portion of the fluid transfer device ofFIG. 6 in the second configuration and identified in FIG. 10 as regionZ₃.

FIG. 12 is an enlarged view of a portion of the fluid transfer device ofFIG. 6 in the first configuration and identified in FIG. 10 as regionZ₄.

FIG. 13 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 14 is a cross-sectional view of the fluid transfer device of FIG.13 taken along the like X₃-X₃, while in a first configuration.

FIG. 15 is an enlarged view of a portion of the fluid transfer device ofFIG. 13 in the first configuration and identified in FIG. 14 as regionZ₅.

FIG. 16 is a cross-sectional view of the fluid transfer device of FIG.13 taken along the line X₃-X₃, while in a second configuration.

FIG. 17 is an enlarged view of a portion of the fluid transfer device ofFIG. 13 in the second configuration and identified in FIG. 16 as regionZ₆.

FIG. 18 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 19 is a cross-sectional view of the fluid transfer device of FIG.18 taken along the like X₄-X₄, while in a first configuration.

FIG. 20 is an enlarged view of a portion of the fluid transfer device ofFIG. 18 in the first configuration and identified in FIG. 19 as regionZ₇.

FIG. 21 is a cross-sectional view of the fluid transfer device of FIG.18 taken along the line X₄-X₄, while in a second configuration.

FIG. 22 is an enlarged view of a portion of the fluid transfer device ofFIG. 18 in the second configuration and identified in FIG. 21 as regionZ₈.

FIG. 23 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 24 is a cross-sectional view of the fluid transfer device of FIG.23 taken along the like X₅-X₅, while in a first configuration.

FIG. 25 is an enlarged view of a portion of the fluid transfer device ofFIG. 23 in the first configuration and identified in FIG. 24 as regionZ₉.

FIG. 26 is a cross-sectional view of the fluid transfer device of FIG.23 taken along the line X₅-X₅, while in a second configuration.

FIG. 27 is an enlarged view of a portion of the fluid transfer device ofFIG. 23 in the second configuration and identified in FIG. 26 as regionZ₁₀.

FIG. 28 is a perspective view of a fluid transfer device in according toan embodiment.

FIG. 29 is an enlarged view of a portion of the fluid transfer device ofFIG. 28 in a first configuration and identified as region Z₁₁.

FIG. 30 is an enlarged view of the portion of the fluid transfer deviceof FIG. 28 in a second configuration and identified as region Z₁₁.

FIG. 31 is a flow chart illustrating a method of transferring a fluid toor from a patient with reduced microbial contamination and inadvertentinjection of undesirable external microbes into a patient's bloodstream.

DETAILED DESCRIPTION

In some embodiments, a fluid transfer device for parenterallytransferring fluid to and/or from a patient includes a housing, aneedle, and an occlusion mechanism. The housing defines a fluid flowpath and is coupleable to a fluid reservoir. The needle has a distal endportion that is configured to be inserted into the patient and aproximal end portion that is configured to be fluidically coupled to thefluid flow path of the housing. The needle defines a lumen between theproximal end portion and the distal end portion. The occlusion mechanismis operable to selectively control a fluid flow between the needle andthe fluid flow path. The occlusion mechanism includes an occlusionmember that is movable between a first configuration where the lumen ofthe needle is obstructed during insertion into the patient and a secondconfiguration where the lumen of the needle is unobstructed after theneedle has been inserted into the patient allowing fluid transfer to orfrom the patient.

In some embodiments, a fluid transfer device for parenterallytransferring fluid to and/or from a patient includes a needle and anocclusion mechanism. The needle has a proximal end portion that isconfigured to be fluidically coupled to a fluid reservoir and a distalend portion that is configured to be inserted into the patient. Theneedle defines a lumen between the proximal end portion and the distalend portion. The occlusion mechanism is operable to selectively controla fluid flow between the patient and the fluid reservoir. The occlusionmechanism has a first configuration where the lumen of the needle isobstructed during insertion into the patient and a second configurationwhere the lumen of the needle is unobstructed after the needle has beeninserted into the patient allowing fluid transfer to or from thepatient. The occlusion mechanism is configured to automaticallytransition from the first configuration to the second configuration whenthe distal end portion of the needle is inserted into the patient.

In some embodiments, a method for transferring a fluid to or from apatient uses a parenteral transfer device that has a needle and anocclusion mechanism. The needle defines a lumen and is configured to beinserted into the patient. The occlusion mechanism is operable toselectively control fluid flow to or from the patient through the lumenof the needle. The method includes disposing the occlusion mechanism ina first configuration in which the lumen of the needle is obstructed toprevent tissue, bodily fluid, and contaminants from entering the lumen.The method includes inserting the needle into the patient and, after theneedle has been inserted into the patient, moving the occlusionmechanism to a second configuration in which the lumen of the needle isunobstructed to allow fluid transfer to or from the patient.

As referred to herein, “bodily fluid” can include any fluid obtainedfrom a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serousfluid, pleural fluid, amniotic fluid, and the like, or any combinationthereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device first touching the body of the patient would be the distalend, while the opposite end of the device (e.g., the end of the devicebeing manipulated by the user) would be the proximal end of the device.

FIGS. 1 and 2 are schematic illustrations of a fluid transfer device 100according to an embodiment, in a first and second configuration,respectively. Generally, the fluid transfer device 100 (also referred toherein as “transfer device”) is configured to facilitate the insertionof a piercing member (e.g., a needle, a trocar, a cannula, or the like)into a patient and to transfer a fluid to or from the patient withreduced contamination from, for example, dermally residing microbes byselectively obstructing a lumen of piercing member.

As shown in FIG. 1, the transfer device 100 includes a housing 101, aneedle 120, and an occlusion mechanism 140. As described in furtherdetail herein, the transfer device 100 can be coupled to a fluidreservoir 130 that can receive a flow of fluid from the transfer device100 and/or transfer a flow of fluid to the transfer device 100. Thehousing 101 can be any suitable shape, size, or configuration and isdescribed in further detail herein with respect to specific embodiments.As shown in FIG. 1, a portion of the housing 101 can be, at leasttemporarily, physically and fluidically coupled to the needle 120. Forexample, in some embodiments, a distal end portion of the housing 101can include a port (not shown in FIGS. 1 and 2) configured to physicallyand fluidically couple to a lock mechanism (not shown in FIGS. 1 and 2)included in the needle 120. In such embodiments, the lock mechanism canbe, for example, a Luer-Lok® or the like that can engage the port. Insome embodiments, the housing 101 can be monolithically formed with atleast a portion of the needle 120. In this manner, a portion of thehousing 101 can receive a bodily fluid from and/or deliver a parenteralfluid to a patient via a lumen 123 defined by the needle 120, asdescribed in further detail herein.

Similarly, the housing 101 is fluidically coupled to the fluid reservoir130. In some embodiments, the proximal end portion of the housing 101can include a port or lock mechanism (e.g., a Luer-Lok®) that can engagea portion of the fluid reservoir 130 to physically and fluidicallycouple the housing 101 to the fluid reservoir 130. In other embodiments,the housing 101 can be coupled to intervening structure such as, forexample, a cannula that is configured to fluidically couple the housing101 to the fluid reservoir 130. While shown in FIGS. 1 and 2 as beingdisposed outside of the housing 101, in some embodiments, the fluidreservoir 130 can be disposed substantially inside the housing 101(e.g., at least a portion of the housing 101 can define the fluidreservoir 130). In this manner, the housing 101 can be configured todefine a fluid flow path 108 between the needle 120 and the fluidreservoir 130, as described in further detail herein. The fluidreservoir 130 can be any suitable reservoir such as, for example, thosedescribed in U.S. Pat. No. 8,197,420 (“the '420 Patent”), entitled,“Systems and Methods for Parenterally Procuring Bodily-Fluid Sampleswith Reduced Contamination,” filed on Dec. 13, 2007, the disclosure ofwhich is incorporated herein by reference in its entirety. In someembodiments, the fluid reservoir can be similar to known fluidreservoirs such as, for example, a BacT/ALERT® SN or a BacT/ALERT® FA,manufactured by BIOMERIEUX, INC. and/or a standard Vacutainer® or aMicrotainer® manufactured by Becton Dickinson. In this manner, theexternal fluid reservoir can be configured such that a negative, orsub-atmospheric, pressure exists within an inner volume of thereservoir. In other embodiments, the fluid reservoir, 130, can containfluids (e.g. saline solution, medications, etc.) intended for deliveryto the patient. In still other embodiments, the fluid reservoir 130 canbe any suitable reservoir, vial, microvial, microliter vial, container,microcontainer, nanovial (e.g., a Nanotainer™ manufactured by Theranos),or the like. In some embodiments, the fluid reservoir 130 can be anysuitable sample or culture bottle such as, for example, aerobic culturebottles, anaerobic culture bottles, and or the like that can include aculture medium or the like. In this manner, the culture bottle canreceive a bodily-fluid sample, which can then be test for the presenceof, for example, Gram-Positive bacteria, Gram-Negative bacteria, yeast,and/or any other organism and subsequently tested using, for example, apolymerase chain reaction (PCR)-based system to identify a specificorganism. In some instances, the culture bottle can receive abodily-fluid sample and the culture medium (disposed therein) can betested for the presence of any suitable organism. If such a test of theculture medium yields a positive result, the culture medium can besubsequently tested using a PCR-based system to identify a specificorganism.

The needle 120 of the transfer device 100 has a proximal end portion 121and a distal end portion 122 and defines the lumen 123 therebetween. Theproximal end portion 121 can physically and fluidically couple theneedle 120 to the housing 101 (e.g., it can be the lock mechanism asdescribed above). In some embodiments, a portion of the housing 101 canbe formed about the proximal end portion 121 of the needle 120, therebycoupling the needle 120 to the housing 101. For example, in someembodiments, the needle 120 can be formed from a metal (e.g., stainlesssteel or the like) or engineered plastics (e.g. polymers,thermoplastics, glass-filled polymers, carbon-filled polymers,ceramic-based polymers, etc.) and the housing 101 can be formed fromthermoplastics (e.g., polyethylene, polypropylene, polyamide,polycarbonate, silicone, urethane and silicon/urethane copolymer(hybrid) materials or the like). In such embodiments, the housing 101can be, for example, over-molded about the proximal end portion 121 ofthe needle 120 to fixedly couple the needle 120 to the housing 101.

The distal end portion 122 of the needle 120 can be inserted into aportion of a patient to deliver a fluid to or receive a fluid from thepatient. For example, in some embodiments, the distal end portion caninclude a tip with a sharp point (e.g., a beveled tip) configured topierce a portion of the patient to dispose the distal end portion 122within, for example, a vein. In other embodiments, a piercing member(e.g., a lumen defining needle) can be movably disposed within theneedle 120 to facilitate the insertion of the distal end portion 120into the portion of the patient (e.g., a trocar). In some embodiments,at least a portion (e.g., the distal end portion) of the needle 120 caninclude an antibiotic formulated to kill bacteria dislodged duringvenipuncture and prevent contamination of the fluid sample and/or thepatient. For example, an exterior surface of the needle 120 and/or aportion of the lumen 123 can include a coating that included thatantibiotic. In some embodiments, the piercing member (e.g., a trocar)can include a coating that included that antibiotic. The distal endportion 122 of the needle 120 can define one or more openings that placethe lumen 123 of the needle 120 in fluid communication with a volumeoutside of the needle 120. For example, in some embodiments, the distalend (e.g., the tip) is substantially open. In other embodiments, thedistal end can be closed and the needle 120 can define one or moreopenings along the circumference of the needle 120 (i.e., along thesidewalls of the needle 120). In such embodiments, the openings can bearranged in any suitable manner. For example, in some embodiments, theopenings can be linearly arranged along a length of the needle 120. Inother embodiments, the openings can be arranged in a linear manner alongthe circumference of the needle 120 (e.g., perpendicular to the lengthof the needle 120). In still other embodiments, the openings can bedisposed in a non-linear arrangement.

The occlusion mechanism 140 of the transfer device 100 can be includedin or coupled to the housing 101. In some embodiments, the occlusionmechanism 140 can be at least partially disposed within the housing 101.The occlusion mechanism 140 can be any suitable mechanism configured todirect, obstruct, or otherwise control a flow of a fluid. Morespecifically, the occlusion mechanism 140 includes an occlusion member141 that can be moved (e.g., pushed, pulled, rotated, slid, bent, orotherwise reconfigured) between a first configuration (FIG. 1) and asecond configuration (FIG. 2). In some embodiments, the occlusion member141 is manually moved. In other embodiments, the occlusion member 141 isurged to move by an actuation of a portion of the occlusion mechanism140. In still other embodiments, the occlusion member 140 canautomatically transform (e.g., reconfigure) from the first configurationto the second configuration, as described in further detail herein.

While in the first configuration, the occlusion member 141 canfluidically isolate at least a portion of the lumen 123 defined by theneedle 120 from the fluid flow path 108 defined by the housing 101 and,once moved to the second configuration (FIG. 2), the occlusion member141 can allow the lumen 123 of the needle 120 to be in fluidcommunication with the fluid flow path 108 of the housing 101. Forexample, in some embodiments, when in the first configuration, theocclusion member 141 can be at least partially disposed within the lumen123 of the needle 120 such that a portion of the lumen 123 that isdistal to the occlusion member 141 is fluidically isolated from thefluid flow path 108 defined by the housing 101. In such embodiments,when in the second configuration, the occlusion member 141 can beremoved from the lumen 123 such that substantially the entire lumen 123of the needle 120 is in fluid communication with the fluid flow path 108defined by the housing 101 (see e.g., FIG. 2).

While the occlusion member 141 is shown in FIGS. 1 and 2 as beingdisposed within the needle 120, in other embodiments, the occlusionmember 141 can be disposed about at least a portion of the needle 120.For example, in some embodiments, the occlusion member 141 can form asheath or the like that substantially surrounds at least a portion ofthe needle 120. In such embodiments, when in the first configuration,the occlusion member 141 can block or surround the one or more openings(described above) defined by the needle 120 and can moved relative tothe needle 120 (i.e., to the second configuration) to substantiallyexpose the one or more openings. In this manner, the lumen 123 of theneedle 120 can be maintained in fluid communication with the fluid flowpath 108 of the housing 101 and the occlusion member 141 can fluidicallyisolate the lumen 123 of the needle 120 from a volume substantiallyoutside of the needle 120. In some embodiments, a portion of the needle120 can form the occlusion mechanism 140. For example, at least aportion of the needle 120 can be formed from a memory shape alloy thatreconfigures when exposed to given conditions (e.g., can move to form anopening when exposed to a temperature within the body). In otherembodiments, at least a portion of the needle 120 can be configured todissolve when exposed to a bodily fluid (e.g., a coating disposed abouta portion of the needle 120 such that when the distal end portion 122 isinserted into the patient, the coating is placed in contact with abodily fluid and thereby is dissolved).

In use, the occlusion member 141 can be in the first configuration tofluidically isolate at least a portion of the lumen 123 of the needle120 from the fluid flow path 108 defined by the housing 101. The distalend portion 122 of the needle 120 can be inserted into a portion of thepatient to be disposed within, for example, a vein. In this manner,dermally residing microbes dislodged during a venipuncture event (e.g.,when the needle 120 and/or the occlusion member 141 pierces the skin ofthe patient) are isolated from the fluid flow path 108 of the housing101. Once the distal end portion 122 of the needle 120 is disposedwithin the vein, the occlusion member 141 can be moved to the secondconfiguration, as indicated by the arrow AA in FIG. 2. For example, theocclusion member 141 can be in the first configuration within a portionof the lumen 123 of the needle 120 when the needle 120 is inserted intothe vein and the occlusion member 141 can be substantially removed fromthe lumen 123 of the needle 120 to place the transfer device 100 in thesecond configuration. In this manner, the lumen 123 of the needle 120 isplaced in fluid communication with a bodily fluid and also placed influid communication with the fluid flow path 108 of the housing 101.

While not shown in FIGS. 1 and 2, in some embodiments, the occlusionmechanism 140 can include an actuator configured to move the occlusionmember 141 between the first and second configuration. For example, insome embodiments, an actuator can be a push button, a slider, a toggle,a pull-tab, a handle, a dial, a lever, an electronic switch, or anyother suitable actuator. In this manner, the actuator can be movablebetween a first position corresponding to the first configuration of theocclusion member 141, and a second position, different from the firstposition, corresponding to the second configuration of the occlusionmember 141. In some embodiments, the actuator can be configured foruni-directional movement. For example, the actuator can be moved fromits first position to its second position, but cannot be moved from itssecond position back to its first position. In this manner, theocclusion member 140 is prevented from being moved to its secondconfiguration before its first configuration.

While shown in FIGS. 1 and 2 as being moved in a transverse directionperpendicular to a length of the needle 120 (e.g., in the direction ofthe arrow AA), in other embodiments, the occlusion member 141 can bemoved between the first configuration and the second configuration inany suitable manner or direction. For example, in some embodiments, theocclusion member 141 can be moved in a rotational motion between thefirst configuration and the second configuration. In other embodiments,the occlusion member 141 can be moved in a proximal or distal direction(e.g., substantially perpendicular to the direction of the arrow AA).

Although not shown in FIGS. 1 and 2, in some embodiments, the transferdevice 100 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from a patient and/or configured to parenterally deliver afluid to the patient. For example, in some embodiments, the transferdevice 100 and/or portion thereof can be included in any of the transferdevices described in U.S. Provisional Patent Application 61/947,076,entitled, “Apparatus and Methods for Disinfection of a SpecimenContainer,” filed Mar. 3, 2014, U.S. patent application Ser. No.14/096,826 entitled, “Sterile Bodily-Fluid Collection Device andMethods,” filed Dec. 4, 2013, or U.S. Pat. No. 8,535,241, entitled“Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Oct. 12,2012 the disclosures of which are incorporated herein by reference intheir entireties. Thus, the transfer device 100 can be used inconjunction with any suitable transfer device to withdraw a sample ofbodily fluid from a patient and/or parenterally deliver a fluid to thepatient with reduced contamination from, for example, dermally residingmicrobes, undesirable bodily tissue, and/or the like.

FIGS. 3-5 illustrate a fluid transfer device 200 (also referred toherein as “transfer device”) according to an embodiment. The transferdevice 200 includes a housing 201, a needle 220, and an occlusionmechanism 240. The needle 220 has a proximal end portion 221 and adistal end portion 222 and defines a lumen 223 therebetween. Theproximal end portion 221 of the needle 220 is physically and fluidicallycoupled to a distal end portion 203 of the housing 201, as describedabove with reference to FIGS. 1 and 2. The distal end portion 222 isconfigured to be inserted into a patient such that a fluid can betransferred to or from the patient via the lumen 223 of the needle 220,as described in further detail herein.

The housing 201 includes a proximal end portion 202, the distal endportion 203, and a medial portion 204. As shown in FIG. 3, the housing201 can have an overall shape substantially similar to known butterflyneedles. The housing 201 can be any suitable shape, size, orconfiguration. For example, while shown in FIG. 3 as being substantiallycylindrical, the housing 201 can be square, rectangular, polygonal,and/or any other non-cylindrical shape. In this manner, the overallshape of the housing 201 can facilitate the handling of the transferdevice 201 by including similar geometric features as known butterflyneedles. The distal end portion 203 of the housing 201 can be physicallyand fluidically coupled to a proximal end portion 221 of the needle 220,as described above. The proximal end portion 202 can be coupled to acannula 205. For example, as shown in FIGS. 4 and 5, a portion of thecannula 205 can be disposed within an opening 207 defined by theproximal end portion 202 of the housing 201. When disposed within theopening 207, the cannula 205 can be physically and fluidically coupledto the medial portion 204 of the housing 201. More specifically, thecannula 205 defines a lumen 209 that is placed in fluid communicationwith a fluid flow path 208 defined by the medial portion 204 of thehousing 201 when the cannula 205 is physically and fluidically coupledthereto.

The medial portion 204 of the housing 201 includes a port 206 that canbe coupled to and/or that can receive a portion of the occlusionmechanism 240. Expanding further, the occlusion mechanism 240 can be,for example, a stylet that includes an engagement member 247 that iscoupled to an occlusion member 241. As shown in FIG. 4, a portion of theocclusion member 241 is disposed within an opening 210 defined by theport 206 to place the engagement member 247 in contact with the port206. The engagement member 247 can be coupled to the port 206 in anysuitable manner. For example, in some embodiments, a surface of theengagement member 247 and a surface of the port can form a threadedcoupling, a press fit (i.e., a friction fit), a snap fit, any number ofmating recesses, and/or the like. As described in further detail herein,the occlusion mechanism 240 can be moved between a first configurationassociated with a first configuration of the transfer device 200 (seee.g., FIG. 4) and a second configuration associated with a secondconfiguration of the transfer device 200 (see e.g., FIG. 5).

As shown in FIG. 4, when the engagement member 247 of the occlusionmechanism 240 is coupled to the port 206 (e.g., the firstconfiguration), a proximal end portion 242 of the occlusion member 241is disposed within the opening 210 and the occlusion member 241 canextend within the fluid flow path 208 of the housing 201 and the lumen223 defined by the needle 220. More specifically, the occlusion member241 can extend within the lumen 223 of the needle 220 such that a distalend portion 243 of the occlusion member 241 is substantially alignedwith the distal end portion 222 of the needle 220. Said another way, adistal end surface of the occlusion member 241 can be substantiallyparallel and aligned (e.g., coplanar) with a distal end surface of theneedle 220.

The arrangement of the occlusion member 241 can be such that an outersurface of the occlusion member 241 is in contact with an inner surfaceof the needle 220 that defines the lumen 223. In this manner, the outersurface of the occlusion member 241 and the inner surface of the needle220 can form a friction fit. Said another way, the outer diameter of atleast the distal end portion 243 of the occlusion member 240 can beslightly larger than the inner diameter of at least the distal endportion 222 of the needle 220, thus, the occlusion member 241 and theneedle 220 can form a friction fit (at least at the distal end portion222 of the needle 220). Therefore, when the distal end portion 243 ofthe occlusion member 241 is aligned with the distal end portion 222 ofthe needle 220 the lumen 223 is substantially fluidically isolated froma volume outside of the needle 220 (e.g., a volume disposed proximallyrelative to the needle 220). In other words, the lumen 223 of the needle220 is obstructed by the occlusion member 241.

In use, the transfer device 200 can be in the first configuration (FIG.4) and a proximal end portion of the cannula 205 can be physically andfluidically coupled to a fluid reservoir (not shown). The fluidreservoir can be any suitable fluid reservoir such as, for example,known fluid reservoirs configured to receive a bodily fluid from apatient and/or configured to deliver a parenteral fluid to the patient.In some embodiments, the fluid reservoir can be, for example, aVacutainer®, a BacT/ALERT® SN, a BacT/ALERT® FA, and/or any of thecontainers, vials, bottles, reservoirs, etc. described above withreference to fluid reservoir 130 of FIGS. 1 and 2. In some embodiments,the external fluid reservoir can be configured such that a negativepressure exists within an inner volume of the reservoir. In otherembodiments, the fluid reservoir can contain a liquid that is intendedto be delivered to the patient. The fluid reservoir can be coupled tothe cannula 205 in any suitable manner. For example, in someembodiments, the cannula 205 can be disposed about a port of the fluidreservoir. In other embodiments, the proximal end portion cannula 205can include a Luer Lok® (not shown) that is configured to matinglycouple to the fluid reservoir. In still other embodiments, the proximalend portion of the cannula 205 can include a piercing member (not shown)that is configured to pierce a piercable septum (e.g., such as thoseincluded in a Vacutainer®).

With the cannula 205 coupled to the fluid reservoir and with thetransfer device 200 and the occlusion mechanism 240 in the firstconfiguration, a user (e.g., a physician, a nurse, a technician, aphlebotomist, or the like) can manipulate the transfer device 200 toinsert the needle 220 into a patient. In this manner, the distal endportion 222 of the needle 220 can pierce the skin of the patient todispose the distal end portion 222 of the needle 220 within, forexample, a vein. In some instances, the venipuncture event (e.g., theinsertion of the distal end portion 222 of the needle 220 into the vein)can dislodge, for example, dermally residing microbes from the insertionpoint. Thus, with the occlusion mechanism 240 in the first configurationwhere the occlusion member 241 obstructs the lumen 223 of the needle220, the lumen 223 is isolated from the dislodged dermally residingmicrobes and/or other undesirable external contaminants that may bepresent on a patient's skin surface (e.g. contaminants, bacteria,fungus, yeast, etc. from: ambient air, healthcare practitioner's fingertransferred when palpating or re-palpating the patient's vein,transferred onto collection supplies during assembly and/or when openingpackaging, etc.).

With the distal end portion 222 of the needle 220 disposed within thevein, the occlusion mechanism 240 can be moved to the secondconfiguration to place the transfer device in the second configuration,as indicated by the arrow BB in FIG. 5. For example, the engagementmember 247 of the occlusion mechanism 240 can be decoupled from the port206 (e.g., unthreaded or pulled) and moved in the direction of the arrowBB such that the occlusion member 241 is removed from the lumen 223 ofthe needle 220 and the fluid flow path 208 of the housing 201. While notshown in FIGS. 3-5, the medial portion 204 can include, for example, aself-sealing septum that is configured to seal an opening that remainsfrom the removal of the occlusion member 241. Therefore, with thecannula 205 fluidically coupled to the fluid reservoir (not shown), themovement of the occlusion mechanism 240 to the second configurationplaces the lumen 223 of the needle 220 in fluid communication with thevein of the patient as well as in fluid communication with the fluidreservoir (e.g., via the fluid flow path 208 of the housing 201 and thelumen 209 of the cannula 205), as indicated by the arrow CC in FIG. 5.Said another way, the lumen 223 of the needle 220 is substantiallyunobstructed such that a flow of fluid substantially free fromcontaminants (e.g., dermally residing microbes and/or other undesirableexternal contaminants) can be transferred to or from the patient via thelumen 223 of the needle 220, the fluid flow path 208 of the housing 201,and the lumen 209 of the cannula 205.

Although not shown in FIGS. 3-5, in some embodiments, the transferdevice 200 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 200 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 100 in FIGS. 1 and 2.

While the occlusion member 240 is shown in FIG. 5 as being manuallymoved from the first configuration to the second configuration, in otherembodiments, a transfer device can include an occlusion mechanism thathas an actuator operable in moving the occlusion mechanism from a firstconfiguration to a second configuration. For example, FIGS. 6-12illustrate a fluid transfer device 300 (also referred to herein as“transfer device”) according to an embodiment. The transfer device 300includes a housing 301, a needle 320, and an occlusion mechanism 340.The needle 320 has a proximal end portion 321 and a distal end portion322 and defines a lumen 323 therebetween. The proximal end portion 321of the needle 320 is physically and fluidically coupled to a shuttlemember 360 of the occlusion member 340, as described in further detailherein. The distal end portion 322 is configured to be inserted into apatient such that a fluid can be transferred to or from the patient viathe lumen 323 of the needle 320, as described in further detail herein.

The housing 301 has a proximal end portion 302, a distal end portion303, and a medial portion 304. As shown in FIG. 6, the housing 301 canhave an overall shape that is substantially similar to the housing 201shown and described with reference to FIG. 3. As shown in FIG. 7, thehousing 301 defines an inner volume 312 between the proximal end portion302 and the distal end portion 303 that substantially encloses and/orhouses the occlusion mechanism 340 and a bias member 370. The proximalend portion 302 and the distal end portion 303 of the housing 301 aresubstantially open. In this manner, the distal end portion 303 canreceive the proximal end portion 321 of the needle 320 that can then bephysically and fluidically coupled to a distal end portion 362 of theshuttle member 360. The proximal end portion 302 can receive a portionof a cannula 305 that can then be physically and fluidically coupled toa proximal end portion 361 of the shuttle member 360. As shown in FIGS.6 and 7, the housing 301 also defines a slot 311 that can movablyreceive a retraction portion 365 of the shuttle member 360 when theocclusion mechanism 340 is moved between a first configuration and asecond configuration, as described in further detail herein. Thus, theoverall size of the housing 301 can remain substantially similar to, forexample, known butterfly needles while disposing the occlusion mechanism340 within the inner volume 312 of the housing 301.

The occlusion mechanism 340 includes an occlusion member 341 and theshuttle member 360. As described above, the distal end portion 362 ofthe shuttle member 360 is physically and fluidically coupled to theproximal end portion 321 of the needle 320. The needle 320 can becoupled to the shuttle member 360 in any suitable manner, such as, forexample, those described above with reference to FIGS. 1 and 2. In otherembodiments, at least a portion of the shuttle member 360 can bemonolithically formed with the needle 320. For example, in someembodiments, at least the portion of the shuttle 360 and the needle 320can be formed from a thermoplastic such as those described above withreference to FIGS. 1 and 2. In such embodiments, the needle 320 can be,for example, a cannula having a sharpened distal end.

As shown in FIG. 7, the shuttle member 360 includes a flange 363 thatcan be in contact with the bias member 370 (e.g., a spring or the like)disposed within the inner volume 312 of the housing 301. Morespecifically, the bias member 370 can be disposed between an innerdistal surface of the housing 301 and a surface of the flange 363. Insome instances, the bias member 370 can be actuated, either directly orindirectly, to move from a first configuration (e.g., a compressedconfiguration) to a second configuration (e.g., an expandedconfiguration). In such instances, the movement of the bias member 370urges the shuttle member 360 to move from a first position relative tothe housing 301 to a second position relative to the housing 301. Forexample, in some embodiments, the shuttle member 360 can be movedrelative to the housing 301 to withdraw the needle 320 and/or theocclusion member 341 after being inserted into the body of a patient.Expanding further, in some embodiments, the housing 301 can include orbe coupled to a cannula (not shown in FIGS. 6-12) that can be adjacentto the needle 320. In such embodiments, the needle 320 can be operablein a venipuncture event and then can be withdrawn (with or without theocclusion member 341) when the shuttle member 360 is moved to the secondposition relative to the housing 301, thereby leaving the cannuladisposed within the patient.

As shown in FIGS. 7-11, the occlusion member 341 has a proximal endportion 342 and a distal end portion 343 and can move between a firstconfiguration and a second configuration. The proximal end portion 342of the occlusion member 341 is coupled to a coupling protrusion 366 thatextends from a surface of the retraction portion 365 of the shuttlemember 360. As shown in FIG. 8, the proximal end portion 342 of theocclusion member 341 can be disposed within a channel defined by thecoupling protrusion 366 to couple the occlusion member 341 thereto. Forexample, the proximal end portion 342 of the occlusion member 341 canform a press fit with a surface of the coupling protrusion 366 thatdefines the channel. In some embodiments, a preloaded stress within theproximal end portion 342 of the occlusion member 341 can maintain theproximal end portion 342 in contact with the surface of the couplingprotrusion 366 defining the channel. Thus, at least a portion of theocclusion member 341 can be coiled about the coupling protrusion 366, asshown in FIG. 8. As described in further detail herein, the occlusionmember 341 can be actuated to move from the first configuration to thesecond configuration such that a larger portion of the occlusion member341 is coiled (i.e., wrapped) about the coupling protrusion 366 of theshuttle member 360.

While in the first configuration, the distal end portion 343 of theocclusion member 341 is disposed within the lumen 323 of the needle 320.As shown in FIG. 9, the occlusion member 341 can extend within the lumen323 of the needle 320 such that a distal end portion 343 of theocclusion member 341 is substantially aligned with the distal endportion 322 of the needle 320. The arrangement of the occlusion member341 and the needle 320 can be substantially similar to or the same asthe arrangement of the occlusion member 241 and the needle 220 describedabove with reference to FIGS. 4 and 5. Thus, when the distal end portion343 of the occlusion member 341 is aligned with the distal end portion322 of the needle 320 the lumen 323 is substantially fluidicallyisolated from a volume outside of the needle 320 (e.g., a volumedisposed proximally relative to the needle 320). In other words, thelumen 323 of the needle 320 is obstructed by the occlusion member 341.

In use, the transfer device 300 can be in the first configuration (FIG.7) and a proximal end portion of the cannula 305 can be physically andfluidically coupled to a fluid reservoir (not shown). The fluidreservoir can be any suitable fluid reservoir such as, for example,those described above with reference to the fluid reservoir 130 of FIGS.1 and 2. With the cannula 305 coupled to the fluid reservoir and withthe transfer device 300 and the occlusion member 341 in the firstconfiguration, a user (e.g., a physician, a nurse, a technician, aphlebotomist, or the like) can manipulate the transfer device 300 toinsert the needle 320 into a patient. In this manner, the distal endportion 322 of the needle 320 can pierce the skin of the patient todispose the distal end portion 322 of the needle 320 within, forexample, a vein. In some instances, the venipuncture event (e.g., theinsertion of the distal end portion 322 of the needle 320 into the vein)can dislodge, for example, dermally residing microbes from the insertionpoint. Thus, with the occlusion member 341 in the first configurationwhere the occlusion member 341 obstructs the lumen 323 of the needle320, the lumen 323 is isolated from the dislodged dermally residingmicrobes and/or other undesirable external contaminants.

With the distal end portion 322 of the needle 320 disposed within thevein, the occlusion member 341 can be moved to the second configurationto place the transfer device 300 in the second configuration, asindicated by the arrow DD in FIG. 10. For example, the user canmanipulate an actuator (not shown in FIGS. 6-12) that is operable inmoving the occlusion member 341 from the first configuration to thesecond configuration. In some embodiments, the actuator can be a pushbutton, a toggle, a slide, an electric circuit, or any other suitableactuator. In some embodiments, the user can, for example, squeeze aregion of the medial portion 304 of the housing 301 to actuate theocclusion member 341. In this manner, the occlusion member 341 can coilabout the coupling protrusion 366 of the retraction portion 365 of theshuttle member 360, as shown in FIG. 11. The coiling motion of theocclusion member 341 moves the distal end portion 343 of the occlusionmember 341 in the proximal direction (e.g., the direction of the arrowDD in FIG. 10), thereby removing the distal end portion 343 of theocclusion member 341 from the lumen 323 of the needle 320 (see e.g.,FIGS. 11 and 12).

Therefore, with the cannula 305 fluidically coupled to the fluidreservoir (not shown), the movement of the occlusion member 341 to thesecond configuration places the lumen 323 of the needle 320 in fluidcommunication with the vein of the patient as well as in fluidcommunication with the fluid reservoir. Expanding further, the proximalend portion 322 of the needle 320 is physically and fluidically coupledto the shuttle member 360 (as described above) such that when theocclusion member 341 is in the second configuration (e.g., the distalend portion 322 is disposed within the lumen 364 of the shuttle member360 (FIG. 11)), the lumen 323 of the needle 320 is placed in fluidcommunication with the fluid reservoir. In this manner, the lumen 323 ofthe needle 320 is substantially unobstructed such that a flow of fluidsubstantially free from contaminates (e.g., dermally residing microbes)can be transferred to or from the patient via the lumen 323 of theneedle 320, the lumen 364 of the shuttle member 360, and the lumen 309of the cannula 305.

As described above, in some instances, once the needle 320 is disposedwithin the vein of the patient, the user can manipulate the transferdevice 300 to move the shuttle member 360 from the first position to thesecond position relative to the housing 301. Thus, the needle 320 andthe occlusion mechanism 340 can be retracted (i.e., moved in theproximal direction) relative to the housing 301. In some embodiments,the arrangement of the transfer device 300 can be such that a cannulacoupled to the distal end portion 303 of the housing 301 is maintainedwithin the vein while the needle 320 and the occlusion mechanism 340 areretracted.

Although not shown in FIGS. 6-12, in some embodiments, the transferdevice 300 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 300 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 100 in FIGS. 1 and 2.

While the occlusion member 341 is shown and described above withreference to FIGS. 6-12 as being disposed within the lumen 323 of theneedle 320, in other embodiments, a transfer device can include anocclusion member that is disposed about a needle. In other words, theneedle of the transfer device can be disposed within a lumen of theocclusion member. For example, FIGS. 13-17 illustrate a fluid transferdevice 400 (also referred to herein as “transfer device” according to anembodiment). The transfer device 400 includes a housing 401, a needle420, and an occlusion mechanism 440 (also referred to herein as“occlusion member”). The needle 420 has a proximal end portion 421 and adistal end portion 422 and defines a lumen 423 therebetween. Theproximal end portion 421 of the needle 420 is physically and fluidicallycoupled to a distal end portion 403 of the housing 401, as describedabove with reference to FIGS. 1 and 2. The distal end portion 422 of theneedle 420 defines a set of openings or apertures 425 disposed along acircumference of the needle 420 that place the lumen 423 of the needle420 in fluid communication with a volume outside of the needle 420. Morespecifically, the distal end portion 422 of the needle 420 has a solid(i.e., closed) tip 424 (see e.g., FIG. 15) that obstructs the distal endof the needle 420. Thus, the openings 425 disposed about thecircumference of the needle 420 place the lumen 423 in fluidcommunication with a volume outside of the needle 420 rather thanneedles 220 and 320 shown above that have a distal end surface that isopen. In this manner, the needle 420 can be inserted into a patient suchthat a fluid can be transferred to or from the patient via the openings425 and the lumen 423 of the needle 420, as described in further detailherein.

The housing 401 has a proximal end portion 402, the distal end portion403, and a medial portion 404. As shown in FIG. 13, the housing 401 canhave an overall shape that is substantially similar to the housing 201shown and described with reference to FIG. 3. The distal end portion 403of the housing 401 can be physically and fluidically coupled to aproximal end portion 421 of the needle 420, as described above. Theproximal end portion 402 can be coupled to a cannula 405. For example,as shown in FIG. 14, a portion of the cannula 405 can be disposed withinan opening 407 defined by the proximal end portion 402 of the housing401. When disposed within the opening 407, the cannula 405 can bephysically and fluidically coupled to the medial portion 404 of thehousing 401, as described above with reference to FIGS. 3-5. Therefore,a lumen 409 defined by the cannula 405 is placed in fluid communicationwith a fluid flow path 408 defined by the medial portion 404 of thehousing 401.

The occlusion mechanism 440 has a proximal end portion 442 and a distalend portion 443, and defines a lumen 444 therebetween. The occlusionmechanism 440 is disposed about a portion of the needle 420 and can bemovable between a first configuration (FIG. 14) and a secondconfiguration (FIG. 16). Similarly stated, the occlusion member(mechanism) 440 is movably disposed about the needle 420 such that atleast a portion of the needle 420 is disposed within the lumen 444 ofthe occlusion member 440. As shown in FIGS. 14 and 15, when the firstconfiguration, the distal end portion 443 of the occlusion member 440 issubstantially aligned with the distal end portion 422 of the needle 420.Said another way, a distal end surface of the occlusion member 440 canbe substantially parallel and aligned (e.g., coplanar) with a distal endsurface of the needle 420, when the occlusion member 440 is in the firstconfiguration.

The arrangement of the occlusion member 440 can be such that an outersurface of the needle 420 is in contact with an inner surface of theocclusion member 440 that defines the lumen 444. In this manner, theinner surface of the occlusion member 440 and the outer surface of theneedle 420 can form a friction fit (e.g., a similar arrangement to theneedle 220 and the occlusion member 221 shown in described above withreference to FIGS. 3-5). As shown in FIG. 15, when the distal endportion 443 of the occlusion member 440 is aligned with the distal endportion 422 of the needle 420, the openings 425 of the needle 420 aredisposed within the lumen 444 of the occlusion member 440. Therefore,the lumen 423 of the needle 420 is substantially fluidically isolatedfrom a volume outside of the needle 420 (e.g., a volume disposedproximally relative to the needle 420). In other words, the openings 425and the lumen 423 of the needle 420 are obstructed by the occlusionmember 440.

In use, the transfer device 400 can be in the first configuration (FIG.14) and a proximal end portion of the cannula 405 can be physically andfluidically coupled to a fluid reservoir (not shown). The fluidreservoir can be any suitable fluid reservoir such as, for example,those described above with reference to the fluid reservoir 130 of FIGS.1 and 2. With the cannula 405 coupled to the fluid reservoir and withthe transfer device 400 in the first configuration, a user (e.g., aphysician, a nurse, a technician, a phlebotomist, or the like) canmanipulate the transfer device 400 to insert the needle 420 into apatient. In this manner, the distal end portion 422 of the needle 420can pierce the skin of the patient to dispose the distal end portion 422of the needle 420 within, for example, a vein. In some instances, thevenipuncture event (e.g., the insertion of the distal end portion 422 ofthe needle 420 into the vein) can dislodge, for example, dermallyresiding microbes from the insertion point. Thus, with the needle 420having the closed tip 424 (FIG. 15) and with the occlusion member 440obstructing the openings 425, the lumen 423 of the needle 420 isisolated from the dislodged dermally residing microbes and/or otherundesirable external contaminants.

Once the distal end portion 422 of the needle 420 is disposed within thevein, the occlusion member 440 can be moved to the second configurationto place the transfer device 400 in the second configuration, asindicated by the arrow EE in FIG. 16. For example, the user can slidethe occlusion member 440 along the length of the needle 420 in the EEdirection (i.e., the proximal direction) such that the proximal endportion 442 of the occlusion member 440 is in contact with the distalend portion 403 of the housing 401. In this manner, the distal endportion 443 of the occlusion member 440 can be moved to a distalposition relative to the openings 425 of the needle 420, as shown inFIG. 17. Thus, the openings 425 of the needle 420 are substantiallyunobstructed and can place the lumen 423 in fluid communication with thevein in which the needle 420 is disposed. Therefore, the movement of theocclusion member 440 to the second configuration places the fluidreservoir (not shown) in fluid communication with the vein of thepatient via the openings 425 and lumen 423 of the needle 420, the fluidflow path 408 of the housing 401, and the lumen 409 of the cannula 405.Said another way, the openings 425 of the needle 420 are substantiallyunobstructed such that a flow of fluid substantially free fromcontaminates (e.g., dermally residing microbes) can be transferred to orfrom the patient via the openings 425 and the lumen 423 of the needle420, the fluid flow path 408 of the housing 401, and the lumen 409 ofthe cannula 405.

While the distal end portion 443 of occlusion member 440 is shown anddescribed in FIGS. 13-17 as beings substantially aligned (e.g.,coplanar) with the distal end portion 422 of the needle 420, in otherembodiments, the distal end portion 443 of the occlusion member 440 canbe offset from the distal tip 424 of the needle 420. For example, insome embodiments, a needle can include a distal tip having a diameterthat is larger than a diameter of the remaining portion of the needle.In such embodiments, an occlusion member can define a lumen with aninner diameter that substantially corresponds to the diameter of theremaining portion of the needle (e.g., other than the distal tip) andthe occlusion member can have an outer diameter that substantiallycorresponds to the diameter of the distal tip of the needle. Thus, whenin a first configuration, the occlusion member can be disposed adjacentto the distal tip such that a substantially smooth transition from thediameter of the distal tip to the outer diameter of the occlusion memberis formed. In some embodiments, the change in diameter from the distaltip to the remaining portion of the needle forms a shoulder that can beany substantially liner and arranged at any given angle. In otherembodiments, the shoulder can be substantially nonlinear. Moreover, thearrangement of the distal surface of the occlusion member can be suchthat the distal surface of the occlusion member matingly couples to theshoulder of the needle.

Although not shown in FIGS. 13-17, in some embodiments, the transferdevice 400 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 100 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 400 in FIGS. 1 and 2.

Although the occlusion member 440 is shown and described in FIGS. 13-17as being translated (slid) along a length of the needle 420 from thefirst configuration to the second configuration, in other embodiments, atransfer device can include an occlusion mechanism (occlusion member)that is rotated relative to the needle to move from a firstconfiguration to a second configuration. For example, FIGS. 18-22illustrate a fluid transfer device 500 (also referred to herein as“transfer device” according to an embodiment). The transfer device 500includes a housing 501, a needle 520, and an occlusion mechanism 540(also referred to herein as “occlusion member”). The needle 520 has aproximal end portion 521 and a distal end portion 522 and defines alumen 523 therebetween. The proximal end portion 521 of the needle 520is physically and fluidically coupled to a distal end portion 503 of thehousing 501, as described above with reference to FIGS. 1 and 2. Thedistal end portion 522 of the needle 520 defines a set of openings 525disposed along a circumference of the needle 520 that place the lumen523 of the needle 520 in fluid communication with a volume outside ofthe needle 520. More specifically, the distal end portion 522 of theneedle 520 has a solid (i.e., closed) tip 524 (see e.g., FIG. 20) thatobstructs the distal end of the needle 520. Thus, the needle 520 can besubstantially similar to the needle 520 shown and described above withreference to FIGS. 13-17. In this manner, the needle 520 can be insertedinto a patient such that a fluid can be transfer to or from the patientvia the openings 525 and the lumen 523 of the needle 520, as describedin further detail herein.

The housing 501 has a proximal end portion 502, the distal end portion503, and a medial portion 504. As shown in FIG. 18, the housing 501 canhave an overall shape that is substantially similar to the housing 201shown and described with reference to FIG. 3. The distal end portion 503of the housing 501 can be physically and fluidically coupled to aproximal end portion 521 of the needle 520, as described above. Theproximal end portion 502 can be coupled to a cannula 505. For example,as shown in FIG. 19, a portion of the cannula 505 can be disposed withinan opening 507 defined by the proximal end portion 502 of the housing501. When disposed within the opening 507, the cannula 505 can bephysically and fluidically coupled to the medial portion 504 of thehousing 501, as described above with reference to FIGS. 3-5. Therefore,a lumen 509 defined by the cannula 505 is placed in fluid communicationwith a fluid flow path 508 defined by the medial portion 504 of thehousing 501.

The occlusion mechanism 540 has a proximal end portion 542 and a distalend portion 543, and defines a lumen 544 therebetween. The proximal endportion 542 of the occlusion member 540 is disposed adjacent to thedistal end portion 503 of the housing 501. The occlusion mechanism 540is disposed about a portion of the needle 520 and can be movable betweena first configuration (FIG. 19) and a second configuration (FIG. 21).Similarly stated, the occlusion member (mechanism) 540 is movablydisposed about the needle 520 such that at least a portion of the needle520 is disposed within the lumen 544 of the occlusion member 540. Asshown in FIGS. 19 and 20, when the first configuration, the distal endportion 543 of the occlusion member 540 is substantially aligned withthe distal end portion 522 of the needle 520 and is arranged relative tothe needle 520 to obstruct the openings 525. Further, the arrangement ofthe occlusion member 540 can be such that an outer surface of the needle520 is in contact with an inner surface of the occlusion member 540 thatdefines the lumen 544. In this manner, the inner surface of theocclusion member 540 and the outer surface of the needle 520 can form afriction fit, as described above with reference to FIGS. 13-17.Therefore, the lumen 523 of the needle 520 is substantially fluidicallyisolated from a volume outside of the needle 520 (e.g., a volumedisposed proximally relative to the needle 520). In other words, theopenings 525 and the lumen 523 of the needle 520 are obstructed by theocclusion member 540.

In use, the transfer device 500 can be in the first configuration (FIG.19) and a proximal end portion of the cannula 505 can be physically andfluidically coupled to a fluid reservoir (not shown). The fluidreservoir can be any suitable fluid reservoir such as, for example,those described above with reference to the fluid reservoir 130 of FIGS.1 and 2. With the cannula 505 coupled to the fluid reservoir and withthe transfer device 500 in the first configuration, a user (e.g., aphysician, a nurse, a technician, a phlebotomist, or the like) canmanipulate the transfer device 500 to insert the needle 520 into apatient. In this manner, the distal end portion 522 of the needle 520can pierce the skin of the patient to dispose the distal end portion 522of the needle 520 within, for example, a vein. In some instances, thevenipuncture event (e.g., the insertion of the distal end portion 522 ofthe needle 520 into the vein) can dislodge, for example, dermallyresiding microbes from the insertion point. Thus, with the needle 520having the closed tip 524 (FIG. 20) and with the occlusion member 540obstructing the openings 525, the lumen 523 of the needle 520 isisolated from the dislodged dermally residing microbes.

Once the distal end portion 522 of the needle 520 is disposed within thevein, the occlusion member 540 can be moved from the first configurationto the second configuration to place the transfer device 500 in thesecond configuration, as indicated by the arrow FF in FIG. 21. Forexample, the user can rotate the occlusion member 540 in the FFdirection such that the distal end portion 543 of the occlusion member540 is rotated relative to the distal end portion 522 of the needle 520.Expanding further, the distal end portion 522 of the needle 520 and thedistal end portion 543 of the occlusion member 540 each include anangles surface (e.g., a sharpened tip). Thus, the rotation of theocclusion member 540 misaligns the distal surfaces of the needle 520 andthe occlusion member 540. In this manner, the occlusion member 540 canbe rotated to expose the openings 525 of the needle 520 such that theopenings 525 are substantially unobstructed (as shown in FIG. 22),thereby placing the lumen 523 in fluid communication with the vein inwhich the needle 520 is disposed.

The movement of the occlusion member 540 to the second configurationplaces the fluid reservoir (not shown) in fluid communication with thevein of the patient via the openings 525 and lumen 523 of the needle520, the fluid flow path 508 of the housing 501, and the lumen 509 ofthe cannula 505. Said another way, the openings 525 of the needle 520are substantially unobstructed such that a flow of fluid substantiallyfree from contaminates (e.g., dermally residing microbes) can betransferred to or from the patient via the openings 525 and the lumen523 of the needle 520, the fluid flow path 508 of the housing 501, andthe lumen 509 of the cannula 505, as indicated by the arrow GG in FIG.21.

While the needle 520 is shown in FIG. 22 as including a single opening525 disposed on the circumference of the needle 520, in otherembodiments, the needle 525 can define any suitable number of openings525 in any suitable arrangement. For example, in some embodiments, theneedle 520 can define more than one opening 525 along the circumferenceof the needle 520 (e.g., perpendicular to the length of the needle 520).In other embodiments, the more than one opening 525 can be linearlyarranged along a length of the needle 520 (e.g., adjacent to theexisting opening 525 shown in FIG. 22). Thus, when the occlusion member540 is rotated relative to the needle 520 the linearly aligned openings525 can be substantially unobstructed. In still other embodiments, theopenings 525 can be disposed in a non-linear arrangement.

Although not shown in FIGS. 18-22, in some embodiments, the transferdevice 500 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 500 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 100 in FIGS. 1 and 2.

While the distal surface of the occlusion member 540 is shown anddescribed as being aligned (e.g., coplanar) with the distal surface ofthe needle 520 when the occlusion member 540 is in the firstconfiguration, in other embodiments, a transfer device can include anocclusion member that at least temporarily circumscribes substantiallythe entire needle. For example, FIGS. 23-27 illustrate a fluid transferdevice 600 (also referred to herein as “transfer device”) according toan embodiment. The transfer device 600 includes a housing 601, a needle620, and an occlusion mechanism 640 (also referred to herein as“occlusion member”). The needle 620 has a proximal end portion 621 and adistal end portion 622 and defines a lumen 623 therebetween. Theproximal end portion 621 of the needle 620 is physically and fluidicallycoupled to a distal end portion 603 of the housing 601, as describedabove with reference to FIGS. 1 and 2. The distal end portion 622 of theneedle 620 defines a set of openings 625 disposed along a circumferenceof the needle 620 that place the lumen 623 of the needle 620 in fluidcommunication with a volume outside of the needle 620. The distal endportion 622 also defines a recessed portion 626 that can be configuredto retain at least a portion of skin that can be dislodged during avenipuncture event. In this manner, the needle 620 can be inserted intoa patient such that a fluid can be transferred to or from the patientvia the openings 625 and the lumen 623 of the needle 620, as describedin further detail herein.

The housing 601 has a proximal end portion 602, the distal end portion603, and a medial portion 604. As shown in FIG. 23, the housing 601 canhave an overall shape that is substantially similar to the housing 201shown and described with reference to FIG. 3. The distal end portion 603of the housing 601 can be physically and fluidically coupled to aproximal end portion 621 of the needle 620, as described above. Theproximal end portion 602 can be coupled to a cannula 605. For example,as shown in FIG. 24, a portion of the cannula 605 can be disposed withinan opening 607 defined by the proximal end portion 602 of the housing601. When disposed within the opening 607, the cannula 605 can bephysically and fluidically coupled to the medial portion 604 of thehousing 601, as described above with reference to FIGS. 3-5. Therefore,a lumen 609 defined by the cannula 605 is placed in fluid communicationwith a fluid flow path 608 defined by the medial portion 604 of thehousing 601.

The occlusion mechanism 640 has a proximal end portion 642 and a distalend portion 643, and defines a lumen 644 therebetween. The proximal endportion 642 of the occlusion member 640 can be coupled to the medialportion 604 of the housing 601. The distal end portion 643 of theocclusion member 640 includes a set of fingers 645 that can selectivelyenclose the distal end portion 622 of the needle 620. As described infurther detail herein, the distal end portion 643 defines a set ofopenings 646 that can be selectively aligned with the openings 625 ofthe needle 620. In this manner, the occlusion mechanism 640 is disposedabout a portion of the needle 620 and can be movable between a firstconfiguration (FIG. 23), a second configuration (FIGS. 24 and 25), and athird configuration (FIGS. 26 and 27). Similarly stated, the occlusionmember (mechanism) 640 is movably disposed about the needle 620 suchthat the needle 620 is at least temporarily disposed within the lumen644 of the occlusion member 640.

As shown in FIG. 23, when in the first configuration, the fingers 645 ofthe occlusion member 640 enclose the distal end portion 622 of theneedle 620. In use, the proximal end portion of the cannula 605 can bephysically and fluidically coupled to a fluid reservoir (not shown). Thefluid reservoir can be any suitable fluid reservoir such as, forexample, those described above with reference to the fluid reservoir 130of FIGS. 1 and 2. With the cannula 605 coupled to the fluid reservoirand with the transfer device 600 in the first configuration, a user(e.g., a physician, a nurse, a technician, a phlebotomist, or the like)can manipulate the transfer device 600 to move the occlusion member 640relative to the needle 620 (indicated by the arrow HH in FIG. 24),thereby placing the occlusion member 640 in the second configuration.For example, in some embodiments, the occlusion member 640 can be formedfrom a relatively flexible material that can include at least a portionthat can be deformed (e.g., such as a bellows portion of the like).Thus, the distal end portion 643 of the occlusion member 640 can bemoved in the proximal direction (i.e., the HH direction) relative to thedistal end portion 622 of the needle 620.

As shown in FIG. 25, the proximal motion of the distal end portion 643of the occlusion member 640 is such that the fingers 645 are moved to anopen configuration to expose the distal end portion 622 of the needle620. Furthermore, the openings 646 of the occlusion member 640 are movedto a proximal position relative to the openings 625 defined by theneedle 620. Therefore, the openings 625 of the needle 620 aresubstantially obstructed by the occlusion member 640. With the occlusionmember 640 in the second configuration, the user can manipulate thetransfer device 600 to insert the needle 620 into a patient. In thismanner, the distal end portion 622 of the needle 620 can pierce the skinof the patient to dispose the distal end portion 622 of the needle 620within, for example, a vein. In some instances, the venipuncture event(e.g., the insertion of the distal end portion 622 of the needle 620into the vein) can dislodge a portion of skin that can include, forexample, dermally residing microbes from the insertion point. Thus, withthe distal end portion 622 of the needle 620 forming the recessedportion 626, the dislodged skin (e.g., a skin “plug”) can be disposedwithin the recessed portion 626. Moreover, with the occlusion member 640obstructing the openings 625, the lumen 623 of the needle 620 isisolated from the dislodged dermally residing microbes.

Once the distal end portion 622 of the needle 620 is disposed within thevein, the occlusion member 640 can be moved from the secondconfiguration to the third configuration, as indicated by the arrow IIin FIG. 26. In some embodiments, the third configuration can besubstantially similar to the first configuration. For example, thedistal end portion 643 of the occlusion member 640 can be moved in thedistal direction (i.e., the II direction) such that the fingers 645 areagain disposed about the distal end portion 622 of the needle 620. Inthis manner, the dislodged skin plug can be retained, by the fingers 645of the occlusion member 640, substantially within the recessed portion626 of the needle 620. Moreover, the openings 646 of the occlusionmember 640 can again be aligned with the openings 625 of the needle 620,as shown in FIG. 27. Thus, the movement of the occlusion member 640 fromthe second configuration to the third configuration places the fluidreservoir (not shown) in fluid communication with the vein of thepatient via the openings 646 of the occlusion member 640, openings 625and lumen 623 of the needle 620, the fluid flow path 608 of the housing601, and the lumen 609 of the cannula 605. Said another way, theopenings 625 of the needle 620 are substantially unobstructed such thata flow of fluid substantially free from contaminates (e.g., dermallyresiding microbes) can be transferred to or from the patient via theopenings 646 of the occlusion member 640, the openings 625 and the lumen623 of the needle 620, the fluid flow path 608 of the housing 601, andthe lumen 609 of the cannula 605.

Although not shown in FIGS. 23-27, in some embodiments, the transferdevice 600 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 600 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 100 in FIGS. 1 and 2.

While the transfer devices 200, 300, 400, 500, and 600 described aboveinclude an occlusion member (e.g., the occlusion members 241, 341, 440,540, and 640), in other embodiments, a transfer device can include aneedle or the like that can transform between a first, obstructedconfiguration and a second, unobstructed configuration. For example,FIGS. 28-30 illustrate a fluid transfer device 700 (also referred toherein as “transfer device”) according to an embodiment. The transferdevice 700 includes a housing 701 and a needle 720. The housing 701 hasa proximal end portion 702, a distal end portion 703, and a medialportion 704. As shown in FIG. 28, the housing 701 can have an overallshape that is substantially similar to the housing 201 shown anddescribed with reference to FIG. 3. The distal end portion 703 of thehousing 701 can be physically and fluidically coupled to a proximal endportion (not shown) of the needle 720, as described in further detailherein. The proximal end portion 702 can be coupled to a cannula 705.For example, a portion of the cannula 705 can be disposed within anopening (not shown) defined by the proximal end portion 702 of thehousing 701. When disposed within the opening (not shown), the cannula705 can be physically and fluidically coupled to the medial portion 704of the housing 701, as described above with reference to FIGS. 3-5.Therefore, a lumen (not shown) defined by the cannula 705 is placed influid communication with a fluid flow path (not shown) defined by themedial portion 704 of the housing 701.

The needle 720 has the proximal end portion (not shown) and a distal endportion 722 and defines a lumen 723 therebetween. The proximal endportion (not shown) of the needle 720 is physically and fluidicallycoupled to the distal end portion 703 of the housing 701, as describedabove with reference to FIGS. 1 and 2. The distal end portion 722 of theneedle 720 includes a distal tip 724 that can be transformable between afirst configuration (FIG. 29) and a second configuration (FIG. 30). Forexample, in some embodiments, at least the distal end portion of theneedle 720 can be formed from a shape memory alloy such as nitinol orthe like. In this manner, the distal tip 724 of the needle 720 can beconfigured to transform from the first configuration to the secondconfiguration when exposed to a given condition such as, for example,when heated to a given temperature, when wetted, and/or the like. Inthis manner, when in the first configuration, the distal tip 724 of theneedle 720 can be substantially closed and when placed in the givencondition the distal tip 724 can transform to an open configuration(e.g., the second configuration).

In use, the transfer device 700 can be in the first configuration (FIG.29) and a proximal end portion of the cannula 705 can be physically andfluidically coupled to a fluid reservoir (not shown). The fluidreservoir can be any suitable fluid reservoir such as, for example,those described above with reference to the fluid reservoir 130 of FIGS.1 and 2. With the cannula 705 coupled to the fluid reservoir and withthe transfer device 700 in the first configuration, a user (e.g., aphysician, a nurse, a technician, a phlebotomist, or the like) canmanipulate the transfer device 700 to insert the needle 720 into apatient. In this manner, the distal end portion 722 of the needle 720can pierce the skin of the patient to dispose the distal end portion 722of the needle 720 within, for example, a vein. In some instances, thevenipuncture event (e.g., the insertion of the distal end portion 722 ofthe needle 720 into the vein) can dislodge, for example, dermallyresiding microbes from the insertion point. Thus, with the needle 720 inthe first configuration, the distal tip 724 is substantially closed(FIG. 29) such that the lumen 723 is substantially obstructed. In thismanner, the lumen 723 of the needle 720 is isolated from the dislodgeddermally residing microbes when the needle 720 is inserted into thepatient. Once the distal end portion 722 of the needle 720 is disposedwithin the vein, the distal tip 724 can transform from the firstconfiguration to the second configuration (FIG. 30). Thus, the distaltip 724 is transformed to an open configuration to place the lumen 723in fluid communication with the vein in which the needle 720 isdisposed. Moreover, the movement of the distal tip 724 to the secondconfiguration places the fluid reservoir (not shown) in fluidcommunication with the vein of the patient via the lumen 723 of theneedle 720, the fluid flow path (not shown) of the housing 701, and thelumen (not shown) of the cannula 705. Said another way, the lumen 723 ofthe needle 720 is substantially unobstructed such that a flow of fluidsubstantially free from contaminates (e.g., dermally residing microbes)can be transferred to or from the patient via the lumen 723 of theneedle 720, the fluid flow path (not shown) of the housing 701, and thelumen (not shown) of the cannula 705.

While the needle 720 is described above as being formed from a materialthat can be reconfigured, in other embodiments, the needle 720 caninclude a coating or the like that can be transformed from the firstconfiguration to the second configuration. For example, in someembodiments, the needle 720 can be coated with a material that candissolve when placed in contact with a fluid (e.g., when disposed in thevein of the patient).

Although not shown in FIGS. 28-30, in some embodiments, the transferdevice 700 and/or a portion thereof can be included in any suitabletransfer device or system that is configured to withdraw a sample ofbodily fluid from and/or parenterally deliver a fluid to a patient,which is substantially free of contamination from, for example, dermallyresiding microbes, undesirable bodily tissue, and/or the like. Forexample, in some embodiments, the transfer device 700 and/or portionthereof can be included in any of the transfer devices described abovewith reference to the transfer device 100 in FIGS. 1 and 2.

FIG. 31 is a flowchart illustrating a method 890 from transferring fluidto or from a patient using a parenteral fluid transfer device, accordingto an embodiment. The parenteral fluid transfer device can be anysuitable transfer device described herein (e.g., the transfer devices100, 200, 300, 400, 500, 600, and/or 700). In this manner, theparenteral fluid transfer device (also referred to herein as “transferdevice”) includes at least a needle and an occlusion mechanism. Theneedle can define a lumen and is configured to be inserted into thepatient. The occlusion mechanism is operable to selectively controlfluid flow to or from a patient through the needle lumen.

The method 890 includes disposing the occlusion mechanism in a firstconfiguration in which the lumen of the needle is obstructed to preventtissue or other undesirable external contaminants from entering thelumen, at 891. For example, in some embodiments, the occlusion mechanismcan include an occlusion member that is disposed within a portion of thelumen of the needle such that at least a portion of the lumen isfluidically isolated from a portion distal to the occlusion member(e.g., as described above with reference to the transfer device 200(FIGS. 3-5) and the transfer device 300 (FIGS. 6-12)). In otherembodiments, the occlusion member can be disposed about the needle andcan be arranged to obstruct an opening, aperture, and/or port defined bythe needle (e.g., as described above with reference to the transferdevice 400 (FIGS. 13-17), the transfer device 500 (FIGS. 18-22), and/orthe transfer device 600 (FIGS. 23-27). In still other embodiments, aportion of the needle can form and/or define the occlusion member (e.g.,as described above with reference to the transfer device 700 (FIGS.28-30).

While in the first configuration, the needle is inserted into thepatient, at 892. In this manner, the distal end portion of the needlecan pierce the skin of the patient to dispose the distal end portion ofthe needle within, for example, a vein. In some instances, thevenipuncture event (e.g., the insertion of the distal end portion of theneedle into the vein) can dislodge, for example, dermally residingmicrobes from the insertion point. In other instances, externalcontaminants and microbes may be present on a patient's skin as noted inabove. Thus, with the occlusion mechanism in the first configurationwhere the occlusion member obstructs the lumen of the needle, the lumenis isolated from the dislodged dermally residing microbes and/or otherundesirable external contaminants.

After the needle has been inserted into the patient, the occlusionmechanism is moved to a second configuration in which the lumen of theneedle is unobstructed to allow fluid transfer to or from the patient,at 893. For example, the occlusion member can be translated, rotated,transformed, dissolved, and/or otherwise reconfigured from the firstconfiguration to the second configuration. In this manner, the occlusionmember can be moved relative to the needle such that the lumen issubstantially unobstructed. In some embodiments, the occlusion membercan be manually moved from the first configuration to the secondconfiguration. In other embodiments, the occlusion member canautomatically move or transform from the first configuration to thesecond configuration. In still other embodiments, the user canmanipulate an actuator or the like that is operable in moving ortransforming the occlusion member from the first configuration to thesecond configuration.

In some embodiments, the needle and/or any other suitable portion of thetransfer device can be physically and fluidically coupled to a fluidreservoir (not shown). The fluid reservoir can be any suitable fluidreservoir such as, for example, known fluid reservoirs configured tocollect and/or deliver a parenteral fluid. Thus, a fluid can betransferred between the patient and the fluid reservoir. In someinstances, the embodiments and methods described herein can be used witha fluid transfer device such as, for example, those described in U.S.Pat. No. 8,535,241, filed Oct. 12, 2012, entitled “Fluid DiversionMechanism for Bodily-Fluid Sampling” and U.S. Provisional PatentApplication Ser. No. 61/712,468, filed Oct. 11, 2012, entitled “Systemsand Methods for Delivering a Fluid to a Patient With ReducedContamination,” the disclosures of which are incorporated herein byreference in their entireties. In such instances, by obstructing thelumen of the needle as shown and described by the embodiments andmethods herein, the quantity (e.g., concentration and/or volumetricratio) of contaminants such as, for example, dermally residing microbes,included in a diversion volume is reduced. Thus, the diversion volumethat is drawn prior to drawing a sample volume can be reduced. Moreover,the sample volume drawn through the lumen of the needle after thediversion volume has been collected can be substantially free fromcontaminants and/or the like that, in some instances, can lead to falsepositive or false negative results when testing the sample volume.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods and steps described above indicate certainevents occurring in certain order, those of ordinary skill in the arthaving the benefit of this disclosure would recognize that the orderingof certain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Additionally, certain steps may be partially completed before proceedingto subsequent steps.

While various embodiments have been particularly shown and described,various changes in form and details may be made. For example, while theocclusion member 541 is shown and described with respect to FIG. 21 asbeing rotated in a single direction, in other embodiments, an actuatorcan be rotated in a first direction (e.g., in the direction of the arrowFF in FIG. 21) and a second direction, opposite the first. In suchembodiments, the rotation in the second direction can be configured tomove a transfer device between the first configuration and the secondconfiguration. In other embodiments, the rotation of the actuator in thesecond direction can be limited.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily fluid flow into a fluid reservoir or for adesired rate of parenteral fluid flow into the patient. Similarly, thesize and/or specific shape of various components can be specificallyselected for a desired fluid reservoir. For example, portions of theembodiments described herein can be modified such that any suitablecontainer, microcontainer, microliter container, vial, microvial,microliter vial, nanovial, sample bottle, culture bottle, etc. can beplaced in contact with a disinfection member to sterilize one or moreinterfaces associated therewith prior to a bodily-fluid being drawn intoa volume so defined.

The invention claimed is:
 1. A device for parenterally transferringfluid between a patient and a fluid container, the device comprising: ahousing defining a fluid flow path configured to transfer a flow offluid; a needle having a distal end portion and a proximal end portion,and defining a lumen therebetween, the distal end portion having aclosed distal end surface and being configured for insertion into thepatient, the distal end portion defining an opening proximal to theclosed distal end surface and in fluid communication with the lumen, theproximal end portion configured to be fluidically coupleable to thehousing to place the lumen of the needle in fluid communication with thefluid flow path; and an occlusion member configured to selectivelyobstruct the opening of the needle to control fluid flow to or from thefluid flow path, the occlusion member having a first state in which adistal end surface of the occlusion member is substantially coplanarwith the closed distal end surface of the needle to obstruct the openingof the needle during insertion into the patient, and a second state inwhich the distal end surface of the occlusion member is nonparallel tothe distal end surface of the needle such that the opening of the needleis unobstructed after the needle has been inserted into the patientallowing fluid transfer between the patient and the fluid flow path. 2.The device of claim 1, wherein the occlusion member is movably disposedon the needle and configured to be in a first position relative to theneedle when in the first state and a second position relative to theneedle when in the second state, the second position being differentfrom the first position.
 3. The device of claim 1, wherein the occlusionmember is rotatably disposed on the needle and configured to be in afirst rotational position relative to the needle when in the first stateand a second rotational position relative to the needle when in thesecond state, the second rotational position being different from thefirst rotational position.
 4. The device of claim 1, wherein the closeddistal end surface of the needle is a beveled distal end surface and thedistal end surface of the occlusion member is a beveled distal endsurface, the beveled distal end surfaces of the needle and the occlusionmember being substantially coplanar when the occlusion member is in thefirst state.
 5. The device of claim 4, wherein the beveled distal endsurfaces of the needle and the occlusion member are offset when theocclusion member is in the second state.
 6. The device of claim 1,further comprising: an actuator coupled to the occlusion member, theactuator configured to switch the occlusion member from the first stateto the second state in response to a force exerted on the actuator. 7.The device of claim 1, wherein the distal end surface of at least one ofthe occlusion member or the needle includes a coating configured toreduce contamination of the distal end surface of at least one of theocclusion member or the needle, respectively.
 8. A device forparenterally transferring bodily fluid from a patient, the devicecomprising: a housing that defines a fluid flow path; a needle having adistal end portion and a proximal end portion, and enclosing a lumenbetween the distal end portion and the proximal end portion, the distalend portion having a closed distal end surface and being configured forinsertion into the patient, the distal end portion defining at least oneopening proximal to the closed distal end surface and in fluidcommunication with the lumen, the proximal end portion being fluidicallycoupled to the housing to place the lumen of the needle in fluidcommunication with the fluid flow path; and an occlusion mechanismconfigured to selectively control fluid flow between the patient and thefluid flow path, the occlusion mechanism having an occlusion membercoupled to and disposed about the needle, the occlusion mechanismconfigured to be in a first state during insertion of the needle intothe patient and configured to be transitioned to a second state afterthe needle is inserted into the patient, the opening of the needle beingobstructed by the occlusion member when the occlusion mechanism is inthe first state and being unobstructed by the occlusion member when theocclusion mechanism is in the second state thereby allowing a volume ofbodily fluid to flow from the patient through the fluid flow path;wherein the occlusion member is rotatably coupled to the needle andconfigured to be in a first rotational position relative to the needlewhen in the occlusion mechanism is in the first state and a secondrotational position relative to the needle when in the occlusionmechanism is in the second state.
 9. The device of claim 8, wherein thehousing is configured to be coupled to a sample reservoir after theneedle is inserted into the patient, the occlusion member configured toobstruct the opening of the lumen during insertion of the needle intothe patient such that a volume of bodily fluid substantially free ofcontaminants is transferred from the patient to the sample reservoir viathe lumen of the needle and the fluid flow path when the occlusionmechanism is transitioned to the second state.
 10. The device of claim8, wherein a distal end surface of the occlusion member is aligned witha distal end surface of the needle when the occlusion mechanism is inthe first state such that the opening of the needle is obstructed duringinsertion into the patient, and the distal end surface of the occlusionmember is misaligned relative to the distal end surface of the needlewhen the occlusion mechanism is in the second state such that theopening of the needle is unobstructed after the needle has been insertedinto the patient.
 11. The device of claim 10, wherein the distal endsurface of the needle is a beveled distal end surface, the distal endsurface of the occlusion member is a beveled distal end surface and issubstantially coplanar with the beveled distal end surface of the needlewhen the occlusion member is in the first state.
 12. The device of claim11, wherein the beveled distal end surfaces of the needle and theocclusion member are non-coplanar when the occlusion member is in thesecond state.
 13. The device of claim 8, wherein the occlusion mechanismincludes an actuator portion, the actuator portion configured totransition the occlusion mechanism from the first state to the secondstate in response to a force exerted on the actuator portion.
 14. Thedevice of claim 13, wherein the actuator portion of the occlusionmechanism configured to rotate in response to the force to transitionthe occlusion member between the first rotational position relative tothe needle and the second rotational position relative to the needle.15. A method for transferring fluid to or from a patient using aparenteral transfer device, the device including a housing defining afluid flow path, a needle having a lumen in fluid communication with thefluid flow path, and an occlusion member operable to selectively controlfluid flow to or from the patient through the lumen of the needle andthe fluid flow path, the needle having a closed distal end surface anddefining an opening proximal to the closed distal surface and in fluidcommunication with the lumen of the needle, the method comprising:disposing the occlusion member in a first state relative to the needlesuch that the opening of the needle is obstructed to prevent at leastone of tissue, bodily fluid, and contaminants from entering the lumen,the closed distal end surface of the needle and a distal end surface ofthe occlusion member being substantially coplanar when the occlusionmember is in the first state; inserting the needle into the patient, theocclusion member being in the first state as the needle is inserted intothe patient; and after the needle has been inserted into the patient,transitioning the occlusion member from the first state to a secondstate such that the distal end surface of the occlusion member isnonparallel to the closed distal end surface of the needle, the openingof the needle being unobstructed when the device is in the second stateto allow a volume of fluid substantially free of tissue and contaminantsto be transferred between the patient and the fluid flow path.
 16. Themethod of claim 15, wherein transitioning the device from the firststate to the second state includes moving the occlusion member from afirst position to a second position.
 17. The method of claim 16, whereinthe occlusion member is moved manually from the first position to thesecond position.
 18. The method of claim 15, wherein transitioning theocclusion member from the first state to the second state includesrotating the occlusion member from a first rotational position to asecond rotational position.
 19. The method of claim 18, wherein thedistal end surface of the occlusion member is coplanar with the distalend surface of the needle when the occlusion member is in the firstrotational position and is non-coplanar to the distal end surface of theneedle when the occlusion member is in the second rotational position.20. The method of claim 18, wherein the device further includes anactuator coupled to the occlusion member, the actuator configured totransition the occlusion member from the first rotational position tothe second rotational position in response to a force exerted on theactuator.